Laboratories in North Dakota are certified as meeting the requirements of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. Certification in the CLIA program allows for Medicare/Medicaid reimbursement for lab services in the nearly 900 entities in the state of North Dakota that do some type of lab test.
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Clinical Laboratory Improvement Amendments (CLIA) Information
- CLIA Application for Certification Form CMS-116
- CLIA Waived List
- CLIA Laboratory Schedules and Fees
- CLIA Test Categorization
- CLIA Approved Proficiency Testing Programs
- State Operations Manual
- Laboratory Tests Performed
- CMS-209 Laboratory Personnel Report
- Federal Regulations
- North Dakota Board of Clinical Laboratory Practice - More information regarding personnel licensure in North Dakota
- Centers for Disease Control and Prevention CLIA Page
- Centers for Medicare and Medicaid Services CLIA Page
- U.S. Food and Drug Administration CLIA Page
- Plan of Correction Template
- Guidelines for Certificate of Provider-Performed Microscopy Procedures (PPMP)
- Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services
- Out of State Laboratories
North Dakota follows the federal CLIA regulations. A North Dakota laboratory must refer specimens for testing only to a CLIA certified laboratory. In order for an out of state reference laboratory to test specimens from North Dakota, the out of state laboratory must have the appropriate CLIA certificate. North Dakota does not license laboratories or laboratory directors. Facilities that only collect specimens do not need to be licensed or certified in our state. - Good Laboratory Practice for Certificate of Waiver laboratories